Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report

Overview

in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.

Full Title of Study: “Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 10, 2021

Interventions

  • Device: sacral neuromodulation
    • Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim┬« device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation

Arms, Groups and Cohorts

  • Experimental: sacral neuromodulation
    • Sacral neuromodulation group, will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim┬« device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation
  • No Intervention: medical therapy
    • this group will be treated with sustained release morphine tablets for pain control

Clinical Trial Outcome Measures

Primary Measures

  • The change of intensity of pain
    • Time Frame: The outcome will be measured at day 15 postoperatively.
    • The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain

Participating in This Clinical Trial

Inclusion Criteria

  • Age, 18-70 – Pain localized to the pelvic and perineal region – The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer – The intensity of pain assessed by VAS (visual analogue pain scale) > 7 – Importantly, the included participants should gain > 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root Exclusion Criteria:
  • Coagulopathy – Infection at site of maneuver – Abnormal Psychological behavior that interfere with integrity of obtained data
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 70 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Assiut University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Diab Fuad Hetta, anesthesia dep. south egypt cancer institute, El methaque st., assuit city, Egypt – Assiut University

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